Clinical medicine profile
Gliclazide / Metformin
Biguanide antidiabetic
- Route
- ORAL
- Schedule
- POM
- ATC
- Not assigned
- PPB status
- registered
This profile needs source confirmation
A traceable source link is not attached to this profile. Confirm prescribing decisions against the current SmPC and Kenya STG/EML.
Safety essentials
The information most likely to change a prescribing or dispensing decision.
Contraindications
- [From component Metformin] Diabetic comma
- severe renal impairment
- hepatic impairment
- keto-acidosis
- cardiac failure
- excessive alcoholic intake
- pancreatitis
- severe infections and trauma
- pregnancy and lactation
- dehydration
- pre-desposition to lactic acidosis
- conditions associated with hypoxaemia
Precautions
- [From component Metformin] Discontinue 2-3 days before surgery
- conditions causing dehydration
- infections
- low calorie diet
- monitor vitamin B12 annually
- patients to be stabilized in hospital when combination therapy is used.
Dosing matrix
Population and organ-function guidance, shown together for faster comparison.
Initial dose: 2.5 mg/500 mg BD. Maintenance Dose: Increase at the rate of 2.5 mg-500 mg/day 14 days depending on the response (Max.10 mg-2000 mg/day in divided doses)
See label paediatric section if present; otherwise use paediatric formulary — do not extrapolate adult doses.
Dose by eGFR; stop if severe impairment or acute kidney injury.
- CrCl 0–120: Confirm renal dosing in product SmPC / primary label.
Avoid in significant hepatic impairment (lactic acidosis risk).
Use, effects & interactions
Indications
- Uncomplicated and non-ketonic diabetes mellitus [maturity onset type II diabetes].
- Clinical selection for Gliclazide / Metformin should follow culture results where relevant, Kenya STG/EML recommendations, and the current product SmPC.
- Class context: Biguanide antidiabetic.
- Confirm site-specific dose, duration and monitoring before prescribing.
Adverse effects
- [From component Metformin] Lactic acidosis in presence of renal failure
- nausea and vomiting
- anorexia
- diarrhoea
- metallic taste
- urticaria
- decreased vitamin B12 absorption.
Drug interactions
Open multi-drug checker ↗- [Gliclazide] First-line type 2 diabetes pharmacotherapy in most guidelines unless contraindicated.
- Educate on sick-day rules.
- Review eGFR at least annually or more if CKD. [Metformin] First-line type 2 diabetes pharmacotherapy in most guidelines unless contraindicated.
- Educate on sick-day rules.
- Review eGFR at least annually or more if CKD.
Mechanism & disposition
Combination product.
Read complete mechanism
Combination product. Component mechanism (Metformin): A biguanide that acts by de-creasing gluconeogenesis and by increasing peripheral metabolism of glucose. Metformin decreases hepatic gluconeogenesis, improves peripheral insulin sensitivity, and reduces intestinal glucose absorption. Does not stimulate insulin secretion — low intrinsic hypoglycaemia risk alone.
Days for glycaemic effect
Taken daily chronically
ORAL
saturable. Not metabolised; renally excreted unchanged. Accumulation in renal impairment drives lactic acidosis risk. [Metformin] Oral absorption saturable. Not metabolised; renally excreted unchanged. Accumulation in renal impairment drives lactic acidosis risk.
Pregnancy, lactation & diet
[Gliclazide] Increasingly used in GDM/PCOS pathways per specialist protocols; insulin remains standard in many settings. [Metformin] Increasingly used in GDM/PCOS pathways per specialist protocols; insulin remains standard in many settings.
Generally considered compatible.
Brands & loaded prices
| Brand | Manufacturer | Pack | Observed price |
|---|---|---|---|
| No reviewed brand listings are linked yet. | |||
Sources & review state
Decision support only. Confirm patient-specific decisions against the current product SmPC, Kenya STG/EML, and professional judgement.